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  1st Edition

Premium Employer

Sun Pharmaceutical Industries

Compare

4.0

based on 5.7k Reviews

Proud winner of ABECA 2024 - AmbitionBox Employee Choice Awards

Top Rated Pharma Company - 2024

2 Sun Pharmaceutical Industries Head Engineering Jobs

Engineering Head - API

SUN PHARMA

4.0

based on 5.7k Reviews

20-25 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Engineering Head - API

Sun Pharmaceutical Industries

posted 28d ago

Job Role Insights

Flexible timing

Key skills for the job

Mechanical Engineering Manual Testing Software Configuration Management CCTV Monitoring Product Life Cycle Management Utility Maintenance

Job Description

Qualification: B.E. / B.Tech (Mechanical)

Experience: 20+ years of API industries experience in the field of engineering services of Plant & Utility maintenance

Responsibilities :

1) Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc.

2) Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.

3) Coordination with CRA, ADD, FDD, MSTG ,PMO ,Plant team and with other CFT Members for regulatory requirements related to Registration, Re-Registration, queries, and variation filing.

4) Product Life Cycle Management: Active participation in Change control committee meeting. - Discussion with different Stakeholders and decision for final variation category (After taking concurrence from CRA, Country RA and Customers if require).

5) Activities related to Variation management - Tracking of Variation filing, approvals and intimation to plant for implementation of changes.

6) Support plant for business continuity of products by filing variations wherever applicable.

7) Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market.

8) Participation in all launch discussions with plant CFT , business team , CRA to identify gap & mitigation plan.

9) Circulation of Regulatory strategies and Guidelines, wherever applicable

10) Support plant during Regulatory Inspections.

11) Monitoring for Product permission s, test licences and lay out archival activities for Local FDA .

Employment Type: Full Time, Permanent

Read full job description

Prepare for Head Engineering roles with real interview advice

What Head Engineering at Sun Pharmaceutical Industries are saying

4.0

Rating based on 2 Head Engineering reviews

Anonymous · Production, Manufacturing & Engineering in Paonta Sahib

Likes

Cost consciousness

Salary - Good

+4 more

Dislikes

Low budgetary support

Work satisfaction - Poor

Read 2 Head Engineering reviews

Head Engineering salary at Sun Pharmaceutical Industries

reported by 7 employees with 16-33 years exp.

₹15 L/yr - ₹32 L/yr

41% less than the average Head Engineering Salary in India

View more details

What Sun Pharmaceutical Industries employees are saying about work life

based on 5.7k employees

51%

64%

42%

97%

Flexible timing

Monday to Saturday

No travel

Day Shift

View more insights

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Sun Pharmaceutical Industries Mumbai Office Location

View all

Mumbai (1) New Delhi (1)

Mumbai, Maharashtra Office

Headquarter

Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN Mumbai, Maharashtra
400063